Background: STEM-AMI outcome is a Phase III, multicenter, randomized, controlled, open label study. The aim pof this study is to demonstrate that G-CSF therapy addition to state of the heart treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patient with reduced left ventriocular EF after successful reperfusion for anterior acute MI. The previous randomized, single blind, phase II study (STEM-AMI trial) demonstrate that administration of G-CSF in “acute phase” of anterior MI with signifiant left ventricular disfunction (EF <45%) can attenuate unfavourable post-infarction remodelling. Since adverse remodelling is the mein predictor of prognosis, the ability of G-CSF to attenuate unfavourable post-infarction remodelling is expected to improve in these patients event-free survival. -EF is known to be unreliable as marker of efficacy of therapy. Many study in acute coronary syndrome demonstrate that global strain directly correlates with the scar area and it is a great predictor of post-infarction remodelling and adverse events as HF or death. -Many studies demonstrated that myocardial strain 2D can quantify infarction area and scar and can predict the possibility of ventricular function improvement. Prymary Objectives: The aim pof this study is to demonstrate that G-CSF therapy addition to state of the heart treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patient with reduced left ventriocular EF after successful reperfusion for anterior acute MI. The evaluation with myocardial 2D strain may be useful to achieve more information about the possible EF improvement and scar reduction. Overview of study: Phase III, multicentre, randomized, controlled, open label study. We studied patients in the HSG Monza Hospital, randomizzazion 1:1 with a web-based system. Patient will be required to attend 6 study assesment during the follow up that will be of 24 months. Treatment: Five (5) mcg/Kg of G-CSF (Filgastrim) has been administreted subcutaneously in the abdomen b.i.d. for 6 days (from day 0 to day 5) to the patient randomized to active treatment, starting within 24 hours after successful PCI and reperfusion. Population: Patients affected by acute anterior STEMI undergoing primary PCI or PCI rescue with persistent occlusion of coronary artery; Time symptom-to-balloon ≥ 2 h e ≤ 24 h if symptoms persist, TIMI flow post PCI>2; Evidence of left ventricular dysfunction (EF biplane <45%) 24h after revascularization; aged >18 years and < 75 years; informed consent signed. State of art: Enrollment is over. Data analysis in progress

(2016). Ruolo della valutazione della funzione ventricolare sinistra mediante strain miocardico 2D in pazienti affetti da infarto miocardico acuto arruolati nello STEM-AMI outcome.. (Tesi di dottorato, Università degli Studi di Milano-Bicocca, 2016).

Ruolo della valutazione della funzione ventricolare sinistra mediante strain miocardico 2D in pazienti affetti da infarto miocardico acuto arruolati nello STEM-AMI outcome.

SCANZIANI, ELISABETTA
2016

Abstract

Background: STEM-AMI outcome is a Phase III, multicenter, randomized, controlled, open label study. The aim pof this study is to demonstrate that G-CSF therapy addition to state of the heart treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patient with reduced left ventriocular EF after successful reperfusion for anterior acute MI. The previous randomized, single blind, phase II study (STEM-AMI trial) demonstrate that administration of G-CSF in “acute phase” of anterior MI with signifiant left ventricular disfunction (EF <45%) can attenuate unfavourable post-infarction remodelling. Since adverse remodelling is the mein predictor of prognosis, the ability of G-CSF to attenuate unfavourable post-infarction remodelling is expected to improve in these patients event-free survival. -EF is known to be unreliable as marker of efficacy of therapy. Many study in acute coronary syndrome demonstrate that global strain directly correlates with the scar area and it is a great predictor of post-infarction remodelling and adverse events as HF or death. -Many studies demonstrated that myocardial strain 2D can quantify infarction area and scar and can predict the possibility of ventricular function improvement. Prymary Objectives: The aim pof this study is to demonstrate that G-CSF therapy addition to state of the heart treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patient with reduced left ventriocular EF after successful reperfusion for anterior acute MI. The evaluation with myocardial 2D strain may be useful to achieve more information about the possible EF improvement and scar reduction. Overview of study: Phase III, multicentre, randomized, controlled, open label study. We studied patients in the HSG Monza Hospital, randomizzazion 1:1 with a web-based system. Patient will be required to attend 6 study assesment during the follow up that will be of 24 months. Treatment: Five (5) mcg/Kg of G-CSF (Filgastrim) has been administreted subcutaneously in the abdomen b.i.d. for 6 days (from day 0 to day 5) to the patient randomized to active treatment, starting within 24 hours after successful PCI and reperfusion. Population: Patients affected by acute anterior STEMI undergoing primary PCI or PCI rescue with persistent occlusion of coronary artery; Time symptom-to-balloon ≥ 2 h e ≤ 24 h if symptoms persist, TIMI flow post PCI>2; Evidence of left ventricular dysfunction (EF biplane <45%) 24h after revascularization; aged >18 years and < 75 years; informed consent signed. State of art: Enrollment is over. Data analysis in progress
GRASSI, GUIDO
STEM; AMI; outcome; STRAIN; 2D
MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE
Italian
IPERTENSIONE E PREVENZIONE DEL RISCHIO CARDIOVASCOLARE - 50R
28
2014/2015
(2016). Ruolo della valutazione della funzione ventricolare sinistra mediante strain miocardico 2D in pazienti affetti da infarto miocardico acuto arruolati nello STEM-AMI outcome.. (Tesi di dottorato, Università degli Studi di Milano-Bicocca, 2016).
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/131831
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